Comparison of the Efficacy of Paclitaxel-releasing Balloon Catheter System Versus the Everolimus-Eluting Stent System for Treatment of In-Stent Restenosis Lesions - Harmonizing Optimal Strategy for Treatment of In-Stent Restenosis Lesions (The HOST-ISR Trial) -

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01093300
First received: March 24, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treating ISR is implantation of another DES into the restenosed segment. However the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions. HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES. The primary endpoint will be in-segment late luminal loss at 9 months angiographical follow-up.


Condition Intervention Phase
In-stent Restenosis Lesion
Device: Paclitaxel-eluting balloon catheter
Device: Everolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Late luminal loss in the analysis segment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Analysis segment is defined as +/- 5mm of the previous stented/inflated segment of the vessel


Secondary Outcome Measures:
  • Late luminal loss in the inflation/in-stent segment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target lesion/vessel revascularization, myocardial infarction [ Time Frame: 1, 2 years ] [ Designated as safety issue: No ]
  • Periprocedural myocardial infarction [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • % diameter stenosis in the analysis segment & in the inflation/in-stent segment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Neointimal volume, % neointimal volume, % volume obstruction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The above parameters will be assessed by IVUS

  • Time interval from device insertion to initiation of deployment [ Time Frame: 0 days ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 1, 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 264
Arms Assigned Interventions
Experimental: Paclitaxel-eluting balloon catheter
Paclitaxel-eluting balloon catheter use for treatment of ISR lesion
Device: Paclitaxel-eluting balloon catheter
Active Comparator: Everolimus-eluting stent
Everolimus-eluting stent use for treatment of ISR lesion
Device: Everolimus-eluting stent

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18y
  • Significant ISR lesion (>50% by visual estimate) of previously stented de novo coronary artery
  • Evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia) or ISR with diameter stenosis > 70%
  • Written, informed consent
  • Target lesion(s) located in a native coronary artery within a previously stented lesion with previous stent diameter of ≥ 2.5 mm and ≤ 4.00 mm
  • Target lesion(s) amenable for percutaneous coronary intervention

Exclusion Criteria:

  • Hypersensitivity to aspirin, clopidogrel, heparin, sirolimus, paclitaxel or radiocontrast media
  • Systemic sirolimus use within 12 months
  • Female of childbearing potential
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia)
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
  • Non-cardiac co-morbid conditions present with life expectancy <1 year or that may result in protocol non-compliance
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • ISR of left main coronary artery
  • Restenosis of two stented bifurcation lesion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093300

Contacts
Contact: Kyung-Woo Park, MD, PhD 82-2-2072-2044 kwparkmd@snu.ac.kr
Contact: Hyo-Soo Kim, MD, PhD 82-2-2072-2226 hyosoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Hyo-Soo Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital IRB, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01093300     History of Changes
Other Study ID Numbers: HOST-ISR trial
Study First Received: March 24, 2010
Last Updated: March 24, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Everolimus
Sirolimus
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 14, 2014